Sacroiliac Joint DisruptionNCT05633888
Post-Market Feasibility Study of the Tenon Medical CATAMARAN™ SI Joint Fusion System
A study testing CATAMARAN SI Joint Fusion System in people with Sacroiliac Joint Disruption and Degenerative Sacroiliitis, run by Tenon Medical at 6 sites in United States.
Trial summary
The purpose of this study is to evaluate the outcomes of patients with sacroiliac joint pain treated with the CATAMARAN SI Joint Fusion System. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sacroiliac Joint Disruption, Degenerative Sacroiliitis
- What is being tested?
- CATAMARAN SI Joint Fusion System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 6 sitesUnited States
- Study dates
- 14 Nov 2022to Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of sacroiliac joint disruption or degenerative sacroiliitis based on ALL of the following:
- Patient has pain at or close to the posterior superior iliac spine (PSIS) with possible radiation into buttocks, posterior thigh or groin and can point with a single finger to the location of pain (Fortin Finger Test), and
- Patient has at least 3 of 5 physical examination maneuvers specific for SI joint pain (Fabers, Compression, Distraction,Thigh thrust, Gaenslen's test, and/or Sacral thrust test), and
- Patient has improvement in lower back pain VAS of at least 50% of the pre injection VAS after fluoroscopic controlled injection of local anesthetic into affected SI joint(s) (including previous documented test <6 months ago)
- Patient has failed conservative care (non-surgical) > 6 months
- Patient has a pre-operative Oswestry Disability Index score > 30%
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- Patient has a pre-operative SI joint pain score of > 50 on a 0-100 mm visual analog scale (VAS)
- Patient, or authorized representative, signs a written Informed Consent form to participate in the study
- Patient is willing and able to complete study follow-up requirements
Who cannot join
- Planned bi-lateral SI joint fixation
- Severe lower back pain due to other causes, such as lumbar disc degeneration, lumbar disc herniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facet degeneration, and lumbar vertebral body fracture (this is done by physical exam, medical history, and MRI/CT/X-ray as required)
- Other known sacroiliac pathology such as: sacral dysplasia, inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA- associated spondyloarthropathy), tumor, acute fracture, crystal arthropathy
- History of recent (<1 year) fracture of the pelvis with documented malunion, non-union of sacrum or ilium or any type of internal fixation of the pelvic ring
- Severe osteoporosis
- Paget's disease, osteomalacia, osteomalacia or other metabolic bone disease
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- Any condition or anatomy that makes treatment with the CATAMARAN SI Joint Fusion System infeasible including deformity
- Known allergy to titanium or titanium alloys
- Morbid obesity
- Active malignancy: a history of any invasive malignancy (except non-melanoma skin cancer), unless the subject has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least five years
- Patient has systemic infection or active infection at the treatment site
- Chronic rheumatologic condition (e.g., rheumatoid arthritis)
- Patient has uncontrolled diabetes
- Patient is currently receiving or seeking worker's compensation, disability remuneration, and/or involved in injury litigation
- Prominent neurologic condition that would interfere with physical therapy
- Patient is pregnant or wishes to become pregnant in the next two years
- Patient is not likely to comply with the follow-up evaluation schedule
- Patient is participating in a clinical trial of another investigational drug or device in which the primary endpoint has not occurred
- Patient has a psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation
- Known or suspected drug or alcohol abuse
- Patient is a prisoner or a ward of the state
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
St. Louis Pain Consultants
Chesterfield, Missouri, 63017
Olayinka Idowu, olayinka.idowu@stl-pain.com
Anne Christopher, MD
- Recruiting
Northwest Specialty Hospital
Coeur d'Alene, Idaho, 83815
Elisa Maples, elisa.maples@nwsh.com
Roland Kent, MD
- Recruiting
Orthopedic Associates of Duluth
Duluth, Minnesota, 55805
Athena Davies, adavies@twu.edu
Mathew Davies, MD
- Recruiting
Vitality Pain Centers
Louisville, Kentucky, 40241
Drew Beacham, dbeacham@vitalitypain.com
Timothy J Beacham, MD
- Recruiting
Comprehensive Pain and Spine Specialists
Muncie, Indiana, 47304
Erika Stogsdill, ehuffman@majorhospital.org
Andrew T Trobridge, MD
- Recruiting
St. George Orthopedic Spine
St. George, Utah, 84790
Mark Stouffer, MD, FAAOS
About this study
Official title: Prospective, Multi-Center, Single Arm Post-Market Feasibility Study of the Tenon Medical CATAMARAN™ SI Joint Fusion System
The purpose of this study is to evaluate the outcomes of patients with sacroiliac joint pain treated with the CATAMARAN SI Joint Fusion System.
Read the detailed description
This is a multi-center post-market study to evaluate the clinical outcomes of patients with sacroiliac joint disruptions or degenerative sacroiliitis treated with the CATAMARAN SI Joint Fusion System.
- Being tested
- CATAMARAN SI Joint Fusion System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CATAMARAN SI Joint Fusion SystemDevice
Placement of the Catamaran Fixation Device
| Study group | Role | What they receive |
|---|---|---|
| CATAMARAN SI Joint Fusion System | Experimental | Placement of the Catamaran Fixation Device Receives: Device: CATAMARAN SI Joint Fusion System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects that meet the definition of Subject Success at 6 months post-procedure
Change from baseline in VAS SI joint pain score to be reduced by at least 20 mm, Lack of device-related serious adverse events, Absence of neurologic worsening related to the sacral spine compared to baseline (unless attributable to a concurrent medical condition or other cause unrelated to the device and/ or study procedure), and Absence of surgical re-intervention (removal, revision, reoperation, or supplemental fixation) for SI joint pain.
Measured: 6 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start14 Nov 2022
- Primary completionJan 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacroiliac Joint DisruptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tenon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633888
- Sponsor's protocol ID
- PTL015
- Status last verified
- Mar 2024
- First submitted
- 14 Nov 2022
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-Center, Single Arm Post-Market Feasibility Study of the Tenon Medical CATAMARAN™ SI Joint Fusion System
- ClinicalTrials.gov ID
- NCT05633888
- Acronym / sponsor ID
- PTL015
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tenon MedicalIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 1 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the outcomes of patients with sacroiliac joint pain treated with the CATAMARAN SI Joint Fusion System.
Detailed description
This is a multi-center post-market study to evaluate the clinical outcomes of patients with sacroiliac joint disruptions or degenerative sacroiliitis treated with the CATAMARAN SI Joint Fusion System.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CATAMARAN SI Joint Fusion System | Experimental | Device: CATAMARAN SI Joint Fusion SystemPlacement of the Catamaran Fixation Device |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of sacroiliac joint disruption or degenerative sacroiliitis based on ALL of the following:
- Patient has failed conservative care (non-surgical) > 6 months
- Patient has a pre-operative Oswestry Disability Index score > 30%
- Patient has a pre-operative SI joint pain score of > 50 on a 0-100 mm visual analog scale (VAS)
- Patient, or authorized representative, signs a written Informed Consent form to participate in the study
Key exclusion criteria (21 listed)
- Planned bi-lateral SI joint fixation
- Severe lower back pain due to other causes, such as lumbar disc degeneration, lumbar disc herniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facet degeneration, and lumbar vertebral body fracture (this is done by physical exam, medical history, and MRI/CT/X-ray as required)
- Other known sacroiliac pathology such as: sacral dysplasia, inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA- associated spondyloarthropathy), tumor, acute fracture, crystal arthropathy
- History of recent (<1 year) fracture of the pelvis with documented malunion, non-union of sacrum or ilium or any type of internal fixation of the pelvic ring
- Severe osteoporosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CATAMARAN SI Joint Fusion SystemPlacement of the Catamaran Fixation Device | Device | CATAMARAN SI Joint Fusion System |
Primary outcome
Proportion of subjects that meet the definition of Subject Success at 6 months post-procedure
Time frame: 6 months post procedure
Change from baseline in VAS SI joint pain score to be reduced by at least 20 mm, Lack of device-related serious adverse events, Absence of neurologic worsening related to the sacral spine compared to baseline (unless attributable to a concurrent medical condition or other cause unrelated to the device and/ or study procedure), and Absence of surgical re-intervention (removal, revision, reoperation, or supplemental fixation) for SI joint pain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CATAMARAN SI Joint Fusion System in people with Sacroiliac Joint Disruption and Degenerative Sacroiliitis, run by Tenon Medical at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Calvin Lincé ((510)274-7483, clince@linceconsulting.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects that meet the definition of Subject Success at 6 months post-procedure (time frame: 6 months post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.